Study of Empagliflozin Plus Carvedilol Versus Carvedilol Alone in Adults With Cirrhosis and Diastolic Heart Dysfunction to Improve Liver Outcomes and Survival

What this Trial Is About

Researchers are evaluating the effects of empagliflozin combined with carvedilol compared to carvedilol alone in patients with cirrhosis who have left ventricular diastolic dysfunction LVDD. This trial focuses on preventing liver-related complications and improving heart function in this group. The study uses updated criteria for diagnosing cirrhotic cardiomyopathy and aims to assess outcomes such as liver decompensation events and survival over about one year. Participants are randomly assigned to receive either empagliflozin 10 mg daily plus carvedilol, which starts at 3.125 mg twice daily and is adjusted weekly to reach a target heart rate, or carvedilol with a placebo pill alongside standard liver disease treatments. The trial maintains a double-blind design with all treatments given for one year, including standard medical care as determined by clinicians. During the study, participants undergo regular assessments including heart function tests, measurement of biomarkers like NT-proBNP, galectin-3, and aldosterone at enrollment, 6 months, and 12 months. Researchers monitor for liver decompensation events, hospitalizations, and death. The primary outcome is a composite of liver-related decompensation or death, with secondary outcomes including improvements in cardiac function and hospitalization rates. The total participation duration is about one year from enrollment.

DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis